Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials

Table 1

The characteristics of the included RCTs.

Study	Region	Type of study	Age	No. of patients	Gender (male/female)	Treatment	Follow-up time	duration of treatment	Outcomes
Stewart, 2009	Multi-centre	Phase III RCT	NR	486	396/90	T1: Gefitinib (250 mg/d); T2: Gefitinib (500 mg/d); C: Methotrexate	2 years	until disease progression	OS, ORR, ADR
Gregoire, 2011	Multi-centre	Phase II RCT	NR	226	198/28	T:RT+Cisplatin+Gefitinib; C:RT+Cisplatin+ placebo	2 years	a maximum of 2 years after randomization or until disease progression, unacceptable toxicity, patient withdrawal, study closure, or death	OS, ORR, PFS, ADR
Argiris, 2013	America	Phase III RCT	60.8; 61.4	270	190/49	T:Gefitinib+Docetaxel; C: Docetaxel+placebo	35 months	until progression	OS, ORR, ADR
Singh, 2013	India	RCT	55; 53	60	48/12	T:RT+gefitinib; C: RT	20 months	90 days; 7 weeks	ORR, ADR
Bhattacharya, 2014	India	RCT	NR	61	54/7	T:RT+Cisplatin+Gefitinib; C: RT+Cisplatin	1 year	7 weeks	ORR, ADR
Kushwaha, 2015	India	RCT	47; 46.9; 46.95	117	111/6	T: Gefitinib; C1: Methotrexate; C2:Methotrexate+ fluorouracil	27 months	8.89 months; 6.42 months; 6.5 months	ORR, ADR
Saini, 2016	India	RCT	50; 54	67	64/3	T:RT+Cisplatin+Gefitinib; C: RT+Cisplatin	42 months; 45 months	9 weeks; 7 weeks	OS, PFS, ORR, ADR

RCTs: randomized controlled trials; NR: no report; T: treatment group; C: control group; OS: overall survival; ORR: overall response rate; PFS: progression free survival; ADR: adverse drug reaction.